84
Participants
Start Date
May 30, 2020
Primary Completion Date
July 8, 2021
Study Completion Date
December 31, 2021
focused power ultrasound treatment
Patients will be placed in the lateral decubitus position and receive treatment with sequential bilateral PRF ablation. Before the treatment, a professional sonographer will be responsible for the length, thickness, and width of PRF sac measurement and localisation, and utilise the ultrasonic diagnostic transducer to delineate the targeted region. The treatment will launch layer-by-layer. After confirming accurate localization of the treatment, layer-by-layer PRF ablation will be performed on the patients. The device generates and delivers a pattern of conic-shaped ultrasound energy to the PRF sac noninvasively. The treatment of FPU-mediated PRF ablation will be implemented once.
Sham treatment
Participants will receive the same procedure as those in the FPU treatment including PRF ultrasonic measurement and localization and focused ultrasound treatment parameters setting, except that no energy will be delivered to the PRF.
JiangSu Province Hospital / The First Affiliated Hospital of Nanjing Medical University, Nanjing
The First Affiliated Hospital with Nanjing Medical University
OTHER